The successful Phase I SBIR program has developed new technology that will enable automated CFD-based design optimization of biomedical devices. The project has developed innovative software that combines the best technologies available in aerospace optimization with those in cardiovascular device development. The Phase I work has clearly demonstrated the effectiveness of such a design approach when applied to new and existing cardiac-assist devices. An automated shape optimization code was run to minimize blood hemolysis in a hemodialysis connector and experimentally validated the results. The computation was verified as being correct and accurate and the agreement with actual experimental data is excellent. The design and development of next- generation CFD-based design optimization software was also started. All Phase I objectives were met or exceeded and proof-of-concept was established. In Phase II, the biomedical significance of the CFD-based design technology will be demonstrated by minimizing hemolysis in clinically realistic biomedical devices via automated geometry shape optimization. A user-friendly commercial-quality software package specifically customized for design and analysis of blood-carrying devices will also be fully implemented. The potential users of this design software include any group engaged in biomedical device development. The software will be the first commercial product to incorporate practical blood damage models for biomedical device analysis and design applications. [unreadable] [unreadable] [unreadable]